Aesthetic and Functional Self-Assessment Following Rhinoseptoplasty in Patients With Unilateral Cleft Lip and Palate

NCT ID: NCT07048418

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-09
• Study Completion Date: 2026-07-01

Brief Summary

Secondary rhino-septoplasty in unilateral cleft lip and palate is the treatment of choice for the correction of aesthetic deformities and the functional impact on ventilation nasal. It remains a difficult treatment. It can be proposed at the end of growth or from the age of 10, depending on nasal obstruction and the severity of the deformity.

The CLEFT-Q questionnaire, validated in 2017, has not yet been widely used in studies. The NOSE questionnaire is an older functional questionnaire that is complementary to the CLEFT-Q.

Cleft lip and palate are rare diseases, accounting for around 30% of all facial clefts, which occur at a rate of 1/750 births in Europe. Deformation of the nose and nasal septum is constant, and more or less severe in unilateral forms.

In the absence of rhino-septoplasty performed during primary cleft repair surgery, deformities persist in children and adolescents. There is a significant aesthetic impact in children, which generally increases in adolescents. The problem of nasal obstruction causes functional discomfort that can be disabling. Open rhino-septoplasty is a standard procedure and is proposed as a secondary treatment in this population . It is indicated during growth in cases of nasal obstruction, or as a function of aesthetic demands.

The hypothesis is that secondary rhino-septoplasty gives long-term satisfaction in patients in terms of aesthetics and respiratory function. The originality of this study lies in the use of the recently validated CLEFT-Q questionnaire to assess the aesthetic and functional satisfaction of patients in adulthood after secondary rhino-septoplasty performed in childhood or adolescence. This long-term follow-up will enable us to assess the stability of aesthetic and functional results.

Conditions

Cleft Lip and Cleft Palate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group of cleft lip and palate patients who underwent rhinoseptoplasty in childhood or adolescence.

Mailing and completing CLEFT-Q and NOSE questionnaires

Intervention Type: OTHER

Mailing and completing CLEFT-Q and NOSE questionnaires

Interventions

Mailing and completing CLEFT-Q and NOSE questionnaires

Mailing and completing CLEFT-Q and NOSE questionnaires

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Unilateral cleft lip and palate Surgery performed at the university hospital as primary surgery (before 12 months of age) without rhino-septoplasty Rhino-septoplasty performed at the university hospital as secondary surgery in childhood or adolescence Aged between 18 and 30 years at the time the CLEFT Q questionnaire was sent out.

Exclusion Criteria

Incomplete clinical file Primary operation elsewhere than at the Montpellier University Hospital Other operation on the nose prior to rhinoseptoplasty Subject unable to read and/or write Impossibility of following the patient during the study period Opposition to participation after a period of reflection Non affiliation to a social security scheme Persons subject to a legal protection measure (placed under safeguard of justice, persons under guardianship or curatorship), Persons participating in another research study including an exclusion period still in progress Pregnant or breast-feeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guillaume Captier, MD-PhD

Role: CONTACT

g-captier@chu-montpellier.fr

+33467338761

Facility Contacts

Guillaume Pr Captier

Role: primary

Other Identifiers

RECHMPL25_0017

Identifier Type: -

Identifier Source: org_study_id